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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04198272
Other study ID # 2019-04-12145
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2021
Est. completion date August 31, 2023

Study information

Verified date February 2024
Source University of California, Berkeley
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This protocol describes an evaluation of the CyberRwanda program, a digital health tool designed with and for adolescents in Rwanda, with a focus on successful futures, broadly, and family planning and reproductive health, more specifically. CyberRwanda is a tablet-based system that provides information on family planning and reproductive health through a set of vignettes. The program also allows users to order and purchase contraceptives, with pick up at nearby participating pharmacies. The program will be implemented in schools in eight districts in Rwanda. The investigators will conduct a 3-arm, cluster, randomized controlled trial to evaluate the impact of CyberRwanda on three primary outcomes: uptake of a contraceptive method, initiation of childbearing, and HIV testing. The investigators will compare two implementation models (facilitated and self-service) to a control arm at the school (cluster) level. The study will enroll 60 schools (20 per arm) and 100 students per school, and follow students for 24 months.


Recruitment information / eligibility

Status Completed
Enrollment 6078
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 19 Years
Eligibility Inclusion Criteria: - Attending a study school at baseline in secondary school levels S1 or S2; - Between 12 and 19 years of age; - If <18 years of age: Assent and parental consent to participate in the study; - If = 18 years of age, informed consent to participate in the study; - Willingness to provide valid contact information for study follow-up purposes. Exclusion Criteria: -

Study Design


Intervention

Behavioral:
CyberRwanda
The CyberRwanda intervention consists of three primary components: 1. STORIES: The CyberRwanda curriculum empowers youth to learn about family planning and reproductive health and employment skills and to set goals for their futures through age-appropriate, interactive, digital and printed stories and activities. 2. LEARN: Q&As and videos related to family planning and reproductive health. 3. SHOP: Youth can directly purchase health products, including menstrual hygiene and contraceptive products (emergency contraception, condoms, and oral contraceptive pills) online. The online health facility finder tool links youth to health facilities for longer-acting methods. All participating pharmacies will be trained to give unbiased, nonjudgmental information and services.

Locations

Country Name City State
Rwanda Society for Family Health Kigali
Rwanda Youth Development Labs Kigali

Sponsors (3)

Lead Sponsor Collaborator
University of California, Berkeley Society for Family Health, Rwanda, Youth Development Labs, Inc dba YLabs

Country where clinical trial is conducted

Rwanda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uptake of a modern contraceptive method The proportion of female youth who report currently using a modern method of contraception at endline (24 months). The primary outcome is expressed as a binary variable, defined as female youth who are currently using a modern method of contraception at endline versus female youth who are not using a modern method of contraception. 24 months
Primary Initiation of childbearing The proportion of female youth who report having ever been pregnant at endline (24 months), regardless of the pregnancy outcome. This outcome is expressed as a binary variable, defined as female youth who report having ever been pregnant versus female youth who report never having been pregnant. 24 months
Primary HIV testing The proportion of youth who have ever had an HIV test at endline (24 months). This outcome is expressed as a binary variable, defined as youth who report having ever been tested for HIV versus youth who report never having tested for HIV. 24 months
Secondary FPRH Knowledge: % of youth that understand the phases of a girl's menstrual cycle The total number of youth who can correctly identify a woman's fertile period, divided by the total number of youth. 24 months
Secondary Behavioral Intentions: % of youth who intend to use a modern contraceptive method in the next 12 months The total number of youth, disaggregated by sex, who are very confident or confident that they will use contraception in the 12 months divided by the total number of youth who anticipate that they will have sexual intercourse in the next 12 months. 24 months
Secondary Self-efficacy Contraceptive Use: % of adolescents who are confident that they could get their partner(s) to use contraceptives/condoms if they desired The total number of youth who state that they agree or strongly agree that they feel confident that they can negotiate contraception and condom use with their partners, divided by the total number of youth. 24 months
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